One-Year Data Support Elixir Medical's DESolve Bioresorbable Scaffold

October 31, 2013—Elixir Medical Corporation (Sunnyvale, CA) announced 1-year results from the DESolve Nx international pivotal clinical trial for the company's CE Mark-approved, fully bioresorbable DESolve novolimus-eluting coronary scaffold system. The trial's Coprincipal Investigator Stefan Verheye, MD, presented the results at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

According to Elixir Medical, the DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil, and New Zealand. This is a multimodality imaging study of bioresorbable scaffolds using angiographic, intravenous ultrasound (IVUS), optical coherence tomography (OCT), and multislice computed tomography (MSCT) at follow-up.

The company reported that the DESolve Nx trial demonstrated a major adverse cardiac events rate of 5.69% at 1 year with no definite scaffold thrombosis.

Results using MSCT, a noninvasive imaging modality to visualize coronary arteries and the manifestations of coronary artery disease, demonstrated a mean lumen area of 5.5 ± 2.2 mm² at 1 year, maintaining the results that were observed at 6 months using other imaging modalities. “The 12-month results of the DESolve scaffold demonstrated sustained clinical outcomes at 1 year, further validating the scaffold as an excellent treatment option for coronary artery disease,” commented Dr. Verheye in Elixir Medical's announcement.

In addition to quantitative coronary angiography (QCA) follow-up on all patients, a subset of 46 patients underwent IVUS and OCT imaging at baseline and 6-month follow-up. At 6 months, Elixir's DESolve demonstrated mean late lumen loss of 0.21 ± 0.34 mm as measured by QCA. IVUS imaging results demonstrated a statistically significant increase of 9% in the lumen area between postprocedure and 6-month follow-up with no late-acquired incomplete scaffold apposition (ISA). OCT imaging results demonstrated a 99% strut coverage rate with a thin and uniform 0.1-mm neointimal layer and confirmed no late-acquired ISA.

Professor Alexandre Abizaid, MD, with the Instituto Dante Pazzanese de Cardiologia in Brazil, conducted a successful live case from Sao Paulo that was broadcast at the TCT conference. The case involved a patient enrolled in the DESolve Nx trial undergoing 18-month follow-up. The angiographic, IVUS, OCT, and MSCT imaging of the coronary vessels treated with the DESolve scaffold, which were projected live at the conference, showed that the coronary vessels of the patient were widely patent with substantial scaffold resorption when viewed using the IVUS and OCT imaging modalities.

In the company's press release, Dr. Abizaid stated, “DESolve is the first product to degrade in about 1 year, demonstrate lumen area increase at 6 months, and maintain the lumen at 18 months, as demonstrated during the live-case follow up. These impressive results can create a paradigm shift in the treatment of patients with cardiovascular disease.”

The fully bioresorbable DESolve scaffold was developed from the company's poly-L lactide-based polymer, which supports the artery while delivering the antiproliferative drug, novolimus. The DESolve scaffold system's features include the ability to achieve increased lumen area at 6 months, demonstrating vascular restoration; the ability to self-appose up to the nominal vessel diameter, resolving minor malapposition; the ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading in approximately 1 year; and the ability to have a wide margin of expansion, stated Elixir Medical.